I cover cardiology news for CardioExchange, a social media website for cardiologists published by the New England Journal of Medicine. I was the editor of TheHeart.Org from its inception in 1999 until December 2008. Following the purchase of TheHeart.Org by WebMD in 2005, I became the editorial director of WebMD professional news, encompassing TheHeart.Org and Medscape Medical News. Prior to joining TheHeart.Org, I was a freelance medical journalist and wrote for a wide variety of medical and computer publications. In 1994-1995 I was a Knight Science Journalism Fellow at MIT. I have a PhD in English from SUNY Buffalo, and I drove a taxicab in New York City before embarking on a career in medical journalism. You can follow me on Twitter at: @cardiobrief.

Medicine Or Mass Murder? Guideline Based on Discredited Research May Have Caused 800,000 Deaths In Europe Over The Last 5 Years

(Updated)– Last summer British researchers provoked concern when they published a paper raising the possibility that by following an established guideline UK doctors may have caused as many as 10,000 deaths each year. Now they have gone a step further and published an estimate that the same guideline may have led to the deaths of as many as 800,00 people in Europe over the last five years. The finding, they write, “is so large that the only context in the last 50 years comes from the largest scale professional failures in the political sphere.” The 800,000 deaths are comparable in size to the worst cases of genocide and mass murder in recent history.

Hannibal Lecter (Photo credit: Wikipedia)

In their new article published in the European Heart Journal, Graham Cole and Darrel Francis continue to explore the extent and implications of the damage caused by the Don Poldermans research misconduct case. [Update: the EHJ article has been removed from the EHJ website. For more on this see the bottom of the story.] The earlier paper demonstrated the potentially large and lethal consequences of the current European Society of Cardiology guideline recommending the liberal use of beta-blockers to protect the heart during surgery for people undergoing non cardiac surgery. The guideline was flawed because it was partly based on unreliable research performed by the disgraced Poldermans (who also served as the chairman of the guideline committee). This may seem like a highly technical question but it effects many millions of people and may, as Francis and his colleagues have demonstrated, led to many thousands of unnecessary deaths.

The new article, the first of two parts, makes no new scientific claims, but instead begins to consider the broader implications of the story. Cole and Francis briefly consider the dilemma of clinicians who may “feel unable to act in contravention of guideline recommendations recognized as ‘state-of-the-art’ by the European Society of Cardiology” and who may even be penalized for failing to follow guidelines.

They note that more than half of the lives lost– potentially more than 400,000– may “have occurred after the research was discredited,” though some of the damage may have been mitigated if doctors changed their practice after reading about the controversy. (There was a 2 year delay after the start of the Poldermans affair until the ESC withdrew the beta-blockade recommendation.)

Cole and Francis argue that much needs to be changed in the application of medical research:

The aviation profession has led the way in systems to prevent, recognize, study, and learn from professional failures. Clinical medicine is now following the same path. We must develop similar systems for research.

In the second part of their article, to be published in two weeks, Cole and Francis will raise the possibility that the responsibility for misconduct lays not just with misguided researchers like Poldermans but also the institutions and the institutional leaders that provide uncritical support to research factories. Further, they will discuss the role of journal editors and, even, journal readers.

Comment: It would be easy to dismiss the views of Cole and Francis as outrageous and overly provocative. After all, with the exceptions of Josef Mengele or Hannibal Lecter, doctors aren’t usually murderers, at least not intentionally. My best guess is that the Don Poldermans of this world strongly believe they are doing good, though that may lead to cutting corners and, then, covering up the corner cutting.

But there are good reasons to think that this sort of provocation is necessary. There is, it has now become clear, a general lack of concern and response to evidence of scientific fraud and misconduct. Journal editors, deans, department chairs, and others seem more concerned with protecting the reputation of their respective institutions than aggressively upholding the integrity of science and research. Of course, defending science and maintaining the reputation of an institution should not be opposing choices. But since they are, perhaps a little provocation is in order.

Update (January 17):

In an highly unusual move the editor of the European Heart Journal has removed the article by Cole and Francis from the journal. No notification or explanation appears on the website. though the headline is still present. I asked Thomas Lüscher, the EHJ editor, for an explanation. Here is the response I received:

Thank you for your mail. As the editor-in-chief of the Eur. Heart J. I have to inform you that this piece, although published online in CardioPulse contains scientific statements that do require peer-review. Unfortunately, this was bypassed by the handling editor and thus I had to act appropriately and correct this mistake.

The authors have been informed about this measure and will hear from us in the near future as soon as the reviews are in. This does not in any way preclude any decision on the article.

Thank you for your understanding, the administrative mistake is on our side. Please note that the Eur. Heart J. is not a newspaper and hence has to follow the outlined rules of peer review.

In response to followup questions I sent to him, Professor Lüscher sent the following additional comment:

I do hope that you understand that the EHJ is high impact journal with stringent peer review. CardioPulse publishes also non-scientific features on societies, countries and alike which are exempt for that process. In this very case, however, as in some others we had in the past, I instructed the editor in charge to discuss with me first whether this needs peer review. Unfortunately, this slipped his attention. I strongly feel that this is required here and one of the authors already communicated his understanding for this. Peer review has nothing to do with censorship, in fact we do this with 3500 manuscripts per year.

In this case, it also appeared necessary as in the meantime also other articles have appeared on the topic. Furthermore, we cannot discuss this issue without referring to the ongoing process within the ESC.

Finally, it is correct that the guidelines have not been retracted as so for the main trial of Poldermans in the NEJM has not been retracted either. Neither the NEJM nor the investigative committee issued such a recommendation. Hence we have to look at this issue in a much balanced manner as the different trials differ in design, molecule, dose, regimen among other. Finally, we have to consider recent registry data. It is the mission of the EHJ to provide first class information and if the reviewers agree with the content of a given paper, this is fine. If not, revision may be required. As I said, we are a scientific journal and not a newspaper.

Thank you for your understanding. You will certainly be informed about the outcome in due time (usually this take 21 days).

Second Update (January 18):

The authors of the “disappeared” article, Graham Cole and Darrel Francis, sent the following statement:

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I am not a cardiologist or physician by any means, and I’m not familiar with the research in question, but are medical associations making recommendations and best practices based on singular research? The FDA in this country requires multiple pre-clinical and clinical trials before allowing a new drug or device to enter the market, or to add new applications of existing drugs and devices. Why wouldn’t a medical association have at least that level of rigor, if not higher, before issuing recommendations (which seem to amount to regulations)? Why, for example, wouldn’t they wait until at least one or two other unrelated research groups had replicated the Polderman’s results? Isn’t that science 101?

Good questions. Guideline committees work with the available research. In this case the guideline committee (chaired by Poldermans) considered a whole bunch of trials, but most of the biggest ones came from Poldermans himself.

There is an even larger question here. There are so many issues and conditions for which the research is inadequate to supply a reliable answer. This problem will not be solved any time soon, unfortunately. In this story I focused more on the particularly insidious effect of fraudulent or unreliable research, which only makes the problem that much worse.

In the case of drug, such as an FDA-approved beta blocker, there is no further FDA approval required for an off-label use, which is left to the discretion of the prescribing physician. Prior to a federal court case decided in 2012, manufacturers could not actively promote off-label uses to physicians. I don’t know the status of appeals in that case, which ruled the prohibition to be unconstitutional.

This issue raises a broad range of issues and lays bare many of the biases built into modern medical care: the bias to believe what’s published (often uncritically); the bias to always do more when doing less is more medically conservative; and the bias to believe that always doing more is always beneficial.

We are in the era of guidelines, some of which, are not well-founded. Yet, they are uncritically accepted widely, and enforced by insurance companies and others. Even when it is clear to doctors that they are wrong, nothing changes. Doctors who challenge the guidelines find themselves in trouble. I find it interested that this is the very situation with lyme disease treatment guidelines, and yet Forbes has consistently backed the wrong side, the flawed guidelines.

I would point out that the lyme guidelines have also damaged a lot of patients, healthwise and financially. And yet the Infectious Diseases Society of America will not change them. They were based on only four clinical trials, with fewer than 300 total patients enrolled. And the treatments offered were ones that patients like them had already had and failed. So, a repeat of the short term treatments on chronic cases will not prove anything. It looks like a set up.

The question in my mind is not why flawed guidelines can be prepared, but why they can continue to be used for long after questions are raised. Why does the medical establishment circle the wagons and refuse all input? Not only that, but ruthlessly pursue questioners, and blacken their reputations. Question their quidelines and if you are a doctor, you are called a quack. The patient who questions them is a nut case.

We have people in powerful positions who are not behaving ethically. And no one is calling them out.

speaking of treatment guidelines, medicine & mass murder … you may be interested in my articles and Round Table Presentations on the use of treatment guidelines to conduct “institutionalized biological warfare experimentation” for vaccine marketing…

“Through the increasing reliance on treatment guidelines, which often end up being ‘non-treatment’ guidelines, the medical system can be used not only to conduct unethical experiments but also to wage biological warfare against an entire population through treatment denial. Indeed, it is not far-fetched to call this the ‘institutionalization of biological warfare.’”

It kind of makes you wonder about dubious benefits of all this ‘statinology’ research over the last 3 decades…with all those moving goal lines set the guideline committees – that of course were not influenced one bit by the manufacturers ;)

What the general public doesn’t understand is that this example is just one episode of the ongoing “mass murder” committed by modern orthodox medicine because of discrediting research data.

For instance, sound but discredited evidence on mammography has shown the test has caused the death of millions of women (read “The Mammogram Myth: The Independent Investigation Of Mammography The Medical Profession Doesn’t Want You To Know About” by Rolf Hefti).

Also, lasting for decades, every year at least 100,000 people get killed in the US alone from the proper use of pharmaceutical drugs (read “Death by Medicine” by C. Dean, et al.).

What “well-meaning” conventional doctor has ever told you about these real facts?

The problem with that piece is the quite obvious ludicrous number estimated of deaths. It’s based on a single meta-analysis largely driven by just one trial:POISE. In my view, POISE has a questionable result because the unusual betablocker dose (too much in a short time), with higher numbers of hypotension and bradycardia in the active arm and consequently more strokes and death. In my opinion, we should not aply this strong term “mass murder” without a extremely solid evidence to do that. Despite not agreeing with the alarmism, the core message is truth: we need better ways to oversight research (and faster corrections of fraudulent ones too). At last, i would like to congratulate you on the excellent work through the years i’ve been following your posts (including investigating frauds).

Lyme Disease guidelines issued by the Infectious Disease Society of America are equally as destructive. “Research” of some of the authors is the basis for many of the guidelines. The IDSA guidelines are known by physicians to be sorely lacking, and in sometimes deadly, but bucking the rotten system has put several physicians out of practice. Dr. Jones in Connecticut is a prime example of what the system is doing to fine physicians. He has treated 10,000 children from all over the world. http://underourskin.com/news/dr-jones-update-crime-and-punishment-ct

Wishes someone was also brave enough to scrutinize every MS drug and whos promoted them all. Its a billion pounds industry and has been going on for decades NO MS drug ever cures MS and thats also why CCSVI is being naysayed. One neuro in CANADA is being sued for naysaying after someone actually scrutinized him many more need to be investigated . ITS SICK TO THE CORE with so many involved in WORLDWIDE. No other disease ever has had to wait over 150 years for help ever and if they did it would of hit headline news thats also why I know even more is going on its easy to work out

Welcome to “modern medicine.” The land of unreliable, profit-driven, conflict-of-interest-filled research. Many medical guidelines are not in place to protect the average consumer. They only function make unethical drug companies filthy rich.

The reality is you’re MD is trained by pharm reps in the parking lot wining and dining physicians. These companies also fund over 80% of all medical journals. Only a fool would discard this conflict of interest and deem these studies “scientific.”

Medicine was hijacked decades ago hence the reason it’s now a LEADING CAUSE OF DEATH here in the US and UK. Politicians are bought daily to pass legislation that only creates more profits for the drug industry.

The game is rigged. Mask the problem with pills instead of troubleshooting to find the real cause. Empower yourself and take action on the foundational health tenets or risk being a victim of the medico-drug cartel.

With that said, there are a small % physicians who save lives in crisis care situations and aren’t quick to dope patients with drugs. Those are real doctors who should be commended.

Funny thing… Dr. Lüscher is currently involved in a plagiarism-trial, where he is accused of copy-pasting a full chapter ina new edition of “Differential Diagnosis in Internal Medicine” without referencing the previous authors.

Why am I not surprised…..conventional medicine is putrid from top to bottom……the system MUST be overhauled legally…..they have proven they can’t discipline themselves….and they are too influential in public health and too in love with money to be trusted at any level………a very bad mixture

The last thing we need is any restraint on trial lawyers….which is called for so frequently….a lot of the public believes the boloney about how the ND’s are suffering because of legal issues…..PLEASE SPARE ME….the poor whitecoats are starving to death…..with their drug kickbacks organ harvesting…stock options…”professional” courtesies…..WAAA WAAA WAA….it’s SOOOOO sad….NOT!